NCT02551939

Brief Summary

A total of 38 Chinese healthy women underwent autologous fat grafting for cosmetic breast augmentation. Breast volumes were measured by magnetic resonance imaging preoperatively and 1 year after the procedure. Furthermore, BREAST-Q was used to analyze the satisfaction and well-being of patients during the preoperative and 1 year post operation.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
Last Updated

September 16, 2015

Status Verified

September 1, 2015

Enrollment Period

3 months

First QC Date

September 13, 2015

Last Update Submit

September 15, 2015

Conditions

Breast Implantation

Outcome Measures

Primary Outcomes (2)

  • Breast volumes were measured by magnetic resonance imaging

    one year

  • BREAST-Questionaire was used to analyze the satisfaction and well-being of patients

    one year

Study Arms (1)

fat graft

EXPERIMENTAL

Autologous Fat Grafting

Procedure: Autologous Fat Grafting

Interventions

Autologous Fat GraftingPROCEDURE

Autologous Fat Grafting

fat graft

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy women agreed to participate in the study

You may not qualify if:

  • Patients who had breast surgery previously
  • Women on the lactation or gestation period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor， head of the Department of Plastic & Cosmetic Surgery

Study Record Dates

First Submitted

September 13, 2015

First Posted

September 16, 2015

Study Start

October 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

September 16, 2015

Record last verified: 2015-09